None 400160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874111031), received between Feb 17, 2023 and Oct 18, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CAUTERY SPATULA TIP (TIP) AS A DISCREPANT RMA ALONG WITH THE PRODUCT RETURNED UNDER PATIENT IDENTIFIER (B)(6) . THERE WAS NO ALLEGED MALFUNCTION OR PATIENT INJURY REPORTED AGAINST THIS PRODUCT. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17955164 ↗
• InjuryFeb 17, 2023Fire; Melted; Detachment of Device or Device Component; Fire; Melted; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ORAL LARYNGECTOMY PROCEDURE, THE SP CAUTERY SPATULA TIP ACCESSORY, WHILE INSTALLED ON THE MONOPOLAR CAUTERY INSTRUMENT, CAUGHT ON FIRE WHILE IN THE ORAL CAVITY. THE INSTRUMENT WAS REMOVED AND THERE WAS REPORTEDLY NO ADDITIONAL PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR WHO WAS NOT PRESENT WHEN THIS EVENT OCCURRED BUT ARRIVED TO THE ROOM ABOUT FIVE MINUTES AFTERWARDS. THE SURGEON AND SURGICAL STAFF INFORMED THE ROBOTICS COORDINATOR THAT THE MONOPOLAR CAUTERY INSTRUMENT WAS BEING USED WITH THE SPATULA TIP. THE PATIENT WAS INTUBATED NASALLY. THE INSTRUMENT REPORTEDLY APPEARED NORMAL DURING INSPECTION AND USE, UNTIL THE SURGEON ACTIVATED CAUTERY WITH IT FOR THE FIRST TIME, THEN THE INSTRUMENT CAUGHT ON FIRE. THE ENERGY SETTINGS WERE UNKNOWN. THE SURGICAL STAFF SAID THEY REMOVED THE INSTRUMENT IMMEDIATELY UPON OBSERVING THE FLAME. THE SURGEON REPORTED TO THE ROBOTICS COORDINATOR THAT THERE WAS NO PATIENT INJURY, BUT THAT TWO PIECES OF THE SPATULA TIP'S WHITE SLEEVE FELL INTO THE PATIENT. THE SURGEON REPORTED RETRIEVING BOTH FRAGMENTS, AND THAT THERE WAS NO ADDITIONAL PATIENT INJURY OR EFFECT ON THE PROC

  Patient problems: Foreign Body In Patient

  MAUDE report 16397942 ↗